F&P SleepStyle
K-Number: K173193 · 2018-08-08
ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2018-08-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
F&P SleepStyle is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2018-08-08 under approval number K173193. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the F&P SleepStyle?
F&P SleepStyle is a medical device that received FDA 510(k) clearance on 2018-08-08. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K173193.
When was F&P SleepStyle approved by the FDA?
F&P SleepStyle received FDA 510(k) clearance on 2018-08-08, under approval number K173193.
What company makes F&P SleepStyle?
F&P SleepStyle is manufactured by Fisher & Paykel Healthcare, Ltd..
What is the FDA product code for F&P SleepStyle?
The FDA product code for F&P SleepStyle is BZD.
Other Devices by Fisher & Paykel Healthcare, Ltd.
K161686F&P InfoSmart
K161412F&P Brevida Nasal Pillows Mask
K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K203449F&P Visairo NIV Mask Range
Related Devices (Code: BZD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.